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Drug overview for ORAQIX (lidocaine/prilocaine):
Generic name: lidocaine/prilocaine
Drug class: Oral Topical Anesthetics
Therapeutic class: Mouth-Throat-Dental - Preparations
Lidocaine hydochloride is an intermediate-acting local anesthetic of the Prilocaine hydrochloride is an intermediate-acting local anesthetic of the amide type.
Lidocaine hydrochloride is used for infiltration anesthesia and for nerve Prilocaine hydrochloride is used in dentistry for infiltration anesthesia and for nerve block anesthesia. block techniques including peripheral, sympathetic, epidural (including caudal), and spinal block anesthesia. Lidocaine has been administered intraperitoneally+ for anesthesia of the peritoneum and pelvic viscera.
Generic name: lidocaine/prilocaine
Drug class: Oral Topical Anesthetics
Therapeutic class: Mouth-Throat-Dental - Preparations
Lidocaine hydochloride is an intermediate-acting local anesthetic of the Prilocaine hydrochloride is an intermediate-acting local anesthetic of the amide type.
Lidocaine hydrochloride is used for infiltration anesthesia and for nerve Prilocaine hydrochloride is used in dentistry for infiltration anesthesia and for nerve block anesthesia. block techniques including peripheral, sympathetic, epidural (including caudal), and spinal block anesthesia. Lidocaine has been administered intraperitoneally+ for anesthesia of the peritoneum and pelvic viscera.
DRUG IMAGES
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The following indications for ORAQIX (lidocaine/prilocaine) have been approved by the FDA:
Indications:
Administration of local anesthesia
Professional Synonyms:
None.
Indications:
Administration of local anesthesia
Professional Synonyms:
None.
The following dosing information is available for ORAQIX (lidocaine/prilocaine):
Prilocaine hydrochloride may be administered by infiltration or by peripheral nerve block. Partially used dental cartridges of the drug should be discarded. Dosage of prilocaine hydrochloride varies with the anesthetic procedure, the degree of anesthesia required, and individual patient response.
The smallest dose required to produce the desired effect should be used. Resuscitative equipment and drugs which may be required for treatment of adverse reactions should be immediately available when prilocaine is administered. For specific procedures and techniques of administration, specialized references should be consulted.
For most routine dental procedures either by infiltration or major nerve block in adults, an initial dose of 1-2 mL (40-80 mg) of a 4% prilocaine hydrochloride solution is usually sufficient. A single dose in adults should not exceed 600 mg (8 mg/kg), and no more than 600 mg should be administered within a 2-hour period in healthy adults. Children younger than 10 years of age rarely require more than 1 mL of a 4% solution (40 mg).
The maximum dose in children younger than 10 years of age who have normal lean body mass and body development may be determined using standard pediatric dose formulas (e.g., Clark's rule).
Dosage of lidocaine hydrochloride varies with the anesthetic procedure, the degree of anesthesia required, and individual patient response. The usual dosages should generally be reduced in children, geriatric patients, debilitated or acutely ill patients, and patients with cardiac and/or hepatic disease. The smallest dose and lowest concentration required to produce the desired effect should be used.
Use of dilute solutions (i.e., 0.25-0.5%) and total dosages not to exceed 3 mg/kg are recommended for induction of IV regional anesthesia in children.
Single doses of lidocaine hydrochloride (for anesthesia other than spinal) should not exceed 4.5 mg/kg (or 300 mg) in healthy adults or 4.5 mg/kg in children younger than 10 years of age.
When administered with epinephrine, lidocaine hydrochloride doses should not exceed 7 mg/kg (or 500 mg) in healthy adults or 7 mg/kg in children younger than 10 years of age. For spinal anesthesia, up to 100 mg of the drug may be given. For continuous epidural or caudal anesthesia, the maximum dose should not be repeated at intervals of less than 1.5
hours. When continuous lumbar or caudal epidural anesthesia is used for nonobstetric procedures, additional drug may be administered if necessary to attain adequate anesthesia. For paracervical block for nonobstetric and obstetric analgesia (including abortion), the maximum recommended dosage (200 mg) should not be repeated at intervals of less than 1.5
hours. For IV regional anesthesia in adults using a 0.5% solution without epinephrine, the dose administered should not exceed 4 mg/kg.
Solutions of 1-2% lidocaine hydrochloride with or without epinephrine and containing no preservatives are used for epidural or caudal anesthesia. To prevent intravascular or subarachnoid injection of a large epidural dose of lidocaine, a test dose (e.g., 2-3 mL of a 1.5% solution) of anesthetic solution should be injected at least 5 minutes prior to administering the total dose. When clinical conditions permit, use of a test dose solution that contains epinephrine (e.g., 10-15 mcg) should be considered to detect inadvertent intravascular injection.
The test dose should be repeated if the patient is moved such that the epidural catheter may have been displaced. Rapid injection of a large, single dose through a catheter should be avoided; instead, the drug should be administered, when feasible, in fractional doses. In epidural anesthesia, 2-3 mL of the indicated solution is usually required for each dermatome to be anesthetized.
In caudal block for production of obstetric analgesia or in epidural thoracic block, 20-30 mL of a 1% solution (200-300 mg) of the drug may be used. For surgical anesthesia with caudal block, 15-20 mL of a 1.5% solution (225-300 mg) is given.
For epidural lumbar analgesia, the dose is 25-30 mL (250-300 mg) of a 1% solution, and for epidural lumbar anesthesia, the recommended dose is 15-20 mL of a 1.5% solution (225-300 mg) or 10-15 mL of a 2% solution (200-300 mg).
A solution of 5% lidocaine hydrochloride with 7.5% dextrose is used for spinal anesthesia in adults and adolescents 16 years of age or older. For obstetric low spinal or saddle-block anesthesia in a normal vaginal delivery, the dose is approximately 1 mL (50 mg).
For cesarean section or deliveries which require intrauterine manipulations, 1.5 mL of the 5% solution (75 mg) may be given. For surgical anesthesia, 1.5-2
mL of the 5% solution (75-100 mg) may be administered.
The following doses of lidocaine hydrochloride have been suggested for various nerve blocks: brachial nerve block, 15-20 mL of a 1.5% solution (225-300 mg); dental nerve block, 1-5 mL of a 2% solution (20-100 mg); intercostal nerve block, 3 mL of a 1% solution (30 mg); paravertebral nerve block, 3-5 mL of a 1% solution (30-50 mg); pudendal nerve block (each side), 10 mL of a 1% solution (100 mg); and paracervical nerve block (each side) for obstetric analgesia, 10 mL of a 1% solution (100 mg). For sympathetic nerve blocks, the following doses may be used: cervical (stellate ganglion) nerve block, 5 mL of a 1% solution (50 mg), and lumbar nerve block, 5-10 mL of a 1% solution (50-100 mg).
For percutaneous infiltration anesthesia, the dose of lidocaine hydrochloride is 1-60 mL of a 0.5 or 1% solution (5-300 mg). For IV regional anesthesia, 10-60 mL of a 0.5%
solution (50-300 mg) may be employed.
For retrobulbar injection, 3-5 mL of a 4% sterile solution (120-200 mg) or 1.7-3 mg/kg is suggested; a portion of the dose is injected retrobulbarly and the remainder may be used to block the facial nerve.
For transtracheal injection, 2-3 mL of a 4% solution (80-120 mg) is administered rapidly. When both transtracheal injection and topical application (oropharyngeal spray) of a 4% solution are needed to achieve complete analgesia, the combined total dose of lidocaine hydrochloride administered by injection and by oropharyngeal spray should not exceed 5 mL of a 4% solution (200 mg) or 3 mg/kg.
Lidocaine hydrochloride with or without epinephrine is used for various dental procedures by infiltration injection or nerve block. In oral infiltration and/or mandibular block, initial doses of 1-5 mL of 2% lidocaine hydrochloride (20-100 mg) with epinephrine 1:100,000 are usually effective. If greater hemostasis is required, epinephrine 1:50,000 may be used.
In children younger than 10 years of age, 0.9-1 mL of 2% lidocaine hydrochloride (18-20 mg) is adequate for a procedure involving 1 tooth (local infiltration), 2-3 teeth (maxillary infiltration), or teeth in an entire quadrant (mandibular block).
The smallest dose required to produce the desired effect should be used. Resuscitative equipment and drugs which may be required for treatment of adverse reactions should be immediately available when prilocaine is administered. For specific procedures and techniques of administration, specialized references should be consulted.
For most routine dental procedures either by infiltration or major nerve block in adults, an initial dose of 1-2 mL (40-80 mg) of a 4% prilocaine hydrochloride solution is usually sufficient. A single dose in adults should not exceed 600 mg (8 mg/kg), and no more than 600 mg should be administered within a 2-hour period in healthy adults. Children younger than 10 years of age rarely require more than 1 mL of a 4% solution (40 mg).
The maximum dose in children younger than 10 years of age who have normal lean body mass and body development may be determined using standard pediatric dose formulas (e.g., Clark's rule).
Dosage of lidocaine hydrochloride varies with the anesthetic procedure, the degree of anesthesia required, and individual patient response. The usual dosages should generally be reduced in children, geriatric patients, debilitated or acutely ill patients, and patients with cardiac and/or hepatic disease. The smallest dose and lowest concentration required to produce the desired effect should be used.
Use of dilute solutions (i.e., 0.25-0.5%) and total dosages not to exceed 3 mg/kg are recommended for induction of IV regional anesthesia in children.
Single doses of lidocaine hydrochloride (for anesthesia other than spinal) should not exceed 4.5 mg/kg (or 300 mg) in healthy adults or 4.5 mg/kg in children younger than 10 years of age.
When administered with epinephrine, lidocaine hydrochloride doses should not exceed 7 mg/kg (or 500 mg) in healthy adults or 7 mg/kg in children younger than 10 years of age. For spinal anesthesia, up to 100 mg of the drug may be given. For continuous epidural or caudal anesthesia, the maximum dose should not be repeated at intervals of less than 1.5
hours. When continuous lumbar or caudal epidural anesthesia is used for nonobstetric procedures, additional drug may be administered if necessary to attain adequate anesthesia. For paracervical block for nonobstetric and obstetric analgesia (including abortion), the maximum recommended dosage (200 mg) should not be repeated at intervals of less than 1.5
hours. For IV regional anesthesia in adults using a 0.5% solution without epinephrine, the dose administered should not exceed 4 mg/kg.
Solutions of 1-2% lidocaine hydrochloride with or without epinephrine and containing no preservatives are used for epidural or caudal anesthesia. To prevent intravascular or subarachnoid injection of a large epidural dose of lidocaine, a test dose (e.g., 2-3 mL of a 1.5% solution) of anesthetic solution should be injected at least 5 minutes prior to administering the total dose. When clinical conditions permit, use of a test dose solution that contains epinephrine (e.g., 10-15 mcg) should be considered to detect inadvertent intravascular injection.
The test dose should be repeated if the patient is moved such that the epidural catheter may have been displaced. Rapid injection of a large, single dose through a catheter should be avoided; instead, the drug should be administered, when feasible, in fractional doses. In epidural anesthesia, 2-3 mL of the indicated solution is usually required for each dermatome to be anesthetized.
In caudal block for production of obstetric analgesia or in epidural thoracic block, 20-30 mL of a 1% solution (200-300 mg) of the drug may be used. For surgical anesthesia with caudal block, 15-20 mL of a 1.5% solution (225-300 mg) is given.
For epidural lumbar analgesia, the dose is 25-30 mL (250-300 mg) of a 1% solution, and for epidural lumbar anesthesia, the recommended dose is 15-20 mL of a 1.5% solution (225-300 mg) or 10-15 mL of a 2% solution (200-300 mg).
A solution of 5% lidocaine hydrochloride with 7.5% dextrose is used for spinal anesthesia in adults and adolescents 16 years of age or older. For obstetric low spinal or saddle-block anesthesia in a normal vaginal delivery, the dose is approximately 1 mL (50 mg).
For cesarean section or deliveries which require intrauterine manipulations, 1.5 mL of the 5% solution (75 mg) may be given. For surgical anesthesia, 1.5-2
mL of the 5% solution (75-100 mg) may be administered.
The following doses of lidocaine hydrochloride have been suggested for various nerve blocks: brachial nerve block, 15-20 mL of a 1.5% solution (225-300 mg); dental nerve block, 1-5 mL of a 2% solution (20-100 mg); intercostal nerve block, 3 mL of a 1% solution (30 mg); paravertebral nerve block, 3-5 mL of a 1% solution (30-50 mg); pudendal nerve block (each side), 10 mL of a 1% solution (100 mg); and paracervical nerve block (each side) for obstetric analgesia, 10 mL of a 1% solution (100 mg). For sympathetic nerve blocks, the following doses may be used: cervical (stellate ganglion) nerve block, 5 mL of a 1% solution (50 mg), and lumbar nerve block, 5-10 mL of a 1% solution (50-100 mg).
For percutaneous infiltration anesthesia, the dose of lidocaine hydrochloride is 1-60 mL of a 0.5 or 1% solution (5-300 mg). For IV regional anesthesia, 10-60 mL of a 0.5%
solution (50-300 mg) may be employed.
For retrobulbar injection, 3-5 mL of a 4% sterile solution (120-200 mg) or 1.7-3 mg/kg is suggested; a portion of the dose is injected retrobulbarly and the remainder may be used to block the facial nerve.
For transtracheal injection, 2-3 mL of a 4% solution (80-120 mg) is administered rapidly. When both transtracheal injection and topical application (oropharyngeal spray) of a 4% solution are needed to achieve complete analgesia, the combined total dose of lidocaine hydrochloride administered by injection and by oropharyngeal spray should not exceed 5 mL of a 4% solution (200 mg) or 3 mg/kg.
Lidocaine hydrochloride with or without epinephrine is used for various dental procedures by infiltration injection or nerve block. In oral infiltration and/or mandibular block, initial doses of 1-5 mL of 2% lidocaine hydrochloride (20-100 mg) with epinephrine 1:100,000 are usually effective. If greater hemostasis is required, epinephrine 1:50,000 may be used.
In children younger than 10 years of age, 0.9-1 mL of 2% lidocaine hydrochloride (18-20 mg) is adequate for a procedure involving 1 tooth (local infiltration), 2-3 teeth (maxillary infiltration), or teeth in an entire quadrant (mandibular block).
Lidocaine hydrochloride may be administered by infiltration or by epidural (including caudal) block, peripheral or sympathetic nerve block, and subarachnoid block. The manufacturers state that only the preservative-free, epinephrine-free 0.5% lidocaine injection should be used for IV regional anesthesia.
Local anesthetics, including lidocaine hydrochloride, have been administered by continuous intra-articular infusion+ (e.g., for control of postoperative pain); however, such use has been associated with chondrolysis. Lidocaine hydrochloride solutions containing preservatives shouldnot be used for spinal or epidural (including caudal) block. Partially used bottles of solutions that do not contain preservatives should be discarded.
Aspiration for blood should be performed prior to injection of lidocaine hydrochloride to avoid inadvertent intravascular administration; however, a negative aspiration does not ensure protection against inadvertent intravascular injection. Local anesthetics should only be administered by clinicians who are experienced in the diagnosis and management of dose-related toxicities and other acute emergencies associated with these agents. Resuscitative equipment, oxygen, drugs, and personnel required for treatment of adverse reactions should be immediately available when lidocaine is administered.
Proper positioning of the patient is extremely important in spinal anesthesia. For specific procedures and techniques of administration, specialized references should be consulted.
Local anesthetics, including lidocaine hydrochloride, have been administered by continuous intra-articular infusion+ (e.g., for control of postoperative pain); however, such use has been associated with chondrolysis. Lidocaine hydrochloride solutions containing preservatives shouldnot be used for spinal or epidural (including caudal) block. Partially used bottles of solutions that do not contain preservatives should be discarded.
Aspiration for blood should be performed prior to injection of lidocaine hydrochloride to avoid inadvertent intravascular administration; however, a negative aspiration does not ensure protection against inadvertent intravascular injection. Local anesthetics should only be administered by clinicians who are experienced in the diagnosis and management of dose-related toxicities and other acute emergencies associated with these agents. Resuscitative equipment, oxygen, drugs, and personnel required for treatment of adverse reactions should be immediately available when lidocaine is administered.
Proper positioning of the patient is extremely important in spinal anesthesia. For specific procedures and techniques of administration, specialized references should be consulted.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for ORAQIX (lidocaine/prilocaine):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Long-acting Bupivacaine/Local Anesthetics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1) CLINICAL EFFECTS: Concurrent or use of local anesthetics with 96 hours of use of long-acting bupivacaine may result in neurologic and cardiovascular toxicity. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also result in methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1) PREDISPOSING FACTORS: Use of additional agents that are associated with methemoglobinemia may further increase the risk of methemoglobinemia.(1) Patients who are at increased risk of developing methemoglobinemia include those with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.(1) PATIENT MANAGEMENT: Avoid the use of other local anesthetics within 96 hours following the administration of long-acting bupivacaine. In patients for whom use is required, monitor for neurologic and cardiovascular effects. Also monitor for methemoglobinemia with use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine.(1,2) Non-liposomal bupivacaine may be administered in the same syringe as bupivacaine liposomal or injected immediately before bupivacaine liposomal as long as the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1) DISCUSSION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposome bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally. Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1) |
BUPIVACAINE LIPOSOME, EXPAREL, XARACOLL, ZYNRELEF |
There are 0 moderate interactions.
The following contraindication information is available for ORAQIX (lidocaine/prilocaine):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Methemoglobinemia |
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Glucose-6-phosphate dehydrogenase (g6Pd) deficiency |
| Heart block |
| Hemolytic anemia from pyruvate kinase and g6PD deficiencies |
| Shock |
There are 0 moderate contraindications.
The following adverse reaction information is available for ORAQIX (lidocaine/prilocaine):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 16 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Dermatitis due to topical drug |
| Rare/Very Rare |
|---|
|
Acute respiratory failure Anaphylaxis Angioedema Bradycardia Bronchospastic pulmonary disease Cardiac arrhythmia CNS toxicity Cyanosis Eyelid edema Headache disorder Hypotension Methemoglobinemia Respiratory depression Seizure disorder Unconsciousness |
There are 20 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Blanching of skin Edema Erythema Pruritus of skin Skin rash Stinging of skin Urticaria |
| Rare/Very Rare |
|---|
|
Acute cognitive impairment Apprehension Blurred vision Dizziness Drowsy Euphoria Muscle fasciculation Nervousness Sensation of cold Sensation of warmth Tinnitus Tremor Vomiting |
The following precautions are available for ORAQIX (lidocaine/prilocaine):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ORAQIX (lidocaine/prilocaine):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ORAQIX (lidocaine/prilocaine)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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